Aspirin in patients undergoing noncardiac surgery

P. J. Devereaux, M. Mrkobrada, D. I. Sessler, K. Leslie, P. Alonso-Coello, A. Kurz, J. C. Villar, A. Sigamani, B. M. Biccard, C. S. Meyhoff, J. L. Parlow, G. Guyatt, A. Robinson, A. X. Garg, R. N. Rodseth, F. Botto, G. Lurati Buse, D. Xavier, M. T V Chan, M. TiboniD. Cook, P. A. Kumar, P. Forget, G. Malaga, E. Fleischmann, M. Amir, J. Eikelboom, R. Mizera, D. Torres, C. Y. Wang, T. VanHelder, P. Paniagua, O. Berwanger, S. Srinathan, M. Graham, L. Pasin, Y. Le Manach, P. Gao, J. Pogue, R. Whitlock, A. Lamy, C. Kearon, C. Baigent, C. Chow, S. Pettit, S. Chrolavicius, S. Yusuf

Research output: Contribution to journalArticle

Abstract

BACKGROUND: There is substantial variability in the perioperative administration of aspirin in patients undergoing noncardiac surgery, both among patients who are already on an aspirin regimen and among those who are not. METHODS: Using a 2-by-2 factorial trial design, we randomly assigned 10,010 patients who were preparing to undergo noncardiac surgery and were at risk for vascular complications to receive aspirin or placebo and clonidine or placebo. The results of the aspirin trial are reported here. The patients were stratified according to whether they had not been taking aspirin before the study (initiation stratum, with 5628 patients) or they were already on an aspirin regimen (continuation stratum, with 4382 patients). Patients started taking aspirin (at a dose of 200 mg) or placebo just before surgery and continued it daily (at a dose of 100 mg) for 30 days in the initiation stratum and for 7 days in the continuation stratum, after which patients resumed their regular aspirin regimen. The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days. RESULTS: The primary outcome occurred in 351 of 4998 patients (7.0%) in the aspirin group and in 355 of 5012 patients (7.1%) in the placebo group (hazard ratio in the aspirin group, 0.99; 95% confidence interval [CI], 0.86 to 1.15; P = 0.92). Major bleeding was more common in the aspirin group than in the placebo group (230 patients [4.6%] vs. 188 patients [3.8%]; hazard ratio, 1.23; 95% CI, 1.01, to 1.49; P = 0.04). The primary and secondary outcome results were similar in the two aspirin strata. CONCLUSIONS: Administration of aspirin before surgery and throughout the early postsurgical period had no significant effect on the rate of a composite of death or nonfatal myocardial infarction but increased the risk of major bleeding. (Funded by the Canadian Institutes of Health Research and others; POISE-2 ClinicalTrials.gov number, NCT01082874.)

Original languageEnglish
Pages (from-to)1494-1503
Number of pages10
JournalNew England Journal of Medicine
Volume370
Issue number16
DOIs
Publication statusPublished - 2014

Fingerprint

Aspirin
Placebos
Myocardial Infarction
Confidence Intervals
Hemorrhage
Clonidine
Blood Vessels

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Devereaux, P. J., Mrkobrada, M., Sessler, D. I., Leslie, K., Alonso-Coello, P., Kurz, A., ... Yusuf, S. (2014). Aspirin in patients undergoing noncardiac surgery. New England Journal of Medicine, 370(16), 1494-1503. https://doi.org/10.1056/NEJMoa1401105

Aspirin in patients undergoing noncardiac surgery. / Devereaux, P. J.; Mrkobrada, M.; Sessler, D. I.; Leslie, K.; Alonso-Coello, P.; Kurz, A.; Villar, J. C.; Sigamani, A.; Biccard, B. M.; Meyhoff, C. S.; Parlow, J. L.; Guyatt, G.; Robinson, A.; Garg, A. X.; Rodseth, R. N.; Botto, F.; Lurati Buse, G.; Xavier, D.; Chan, M. T V; Tiboni, M.; Cook, D.; Kumar, P. A.; Forget, P.; Malaga, G.; Fleischmann, E.; Amir, M.; Eikelboom, J.; Mizera, R.; Torres, D.; Wang, C. Y.; VanHelder, T.; Paniagua, P.; Berwanger, O.; Srinathan, S.; Graham, M.; Pasin, L.; Le Manach, Y.; Gao, P.; Pogue, J.; Whitlock, R.; Lamy, A.; Kearon, C.; Baigent, C.; Chow, C.; Pettit, S.; Chrolavicius, S.; Yusuf, S.

In: New England Journal of Medicine, Vol. 370, No. 16, 2014, p. 1494-1503.

Research output: Contribution to journalArticle

Devereaux, PJ, Mrkobrada, M, Sessler, DI, Leslie, K, Alonso-Coello, P, Kurz, A, Villar, JC, Sigamani, A, Biccard, BM, Meyhoff, CS, Parlow, JL, Guyatt, G, Robinson, A, Garg, AX, Rodseth, RN, Botto, F, Lurati Buse, G, Xavier, D, Chan, MTV, Tiboni, M, Cook, D, Kumar, PA, Forget, P, Malaga, G, Fleischmann, E, Amir, M, Eikelboom, J, Mizera, R, Torres, D, Wang, CY, VanHelder, T, Paniagua, P, Berwanger, O, Srinathan, S, Graham, M, Pasin, L, Le Manach, Y, Gao, P, Pogue, J, Whitlock, R, Lamy, A, Kearon, C, Baigent, C, Chow, C, Pettit, S, Chrolavicius, S & Yusuf, S 2014, 'Aspirin in patients undergoing noncardiac surgery', New England Journal of Medicine, vol. 370, no. 16, pp. 1494-1503. https://doi.org/10.1056/NEJMoa1401105
Devereaux PJ, Mrkobrada M, Sessler DI, Leslie K, Alonso-Coello P, Kurz A et al. Aspirin in patients undergoing noncardiac surgery. New England Journal of Medicine. 2014;370(16):1494-1503. https://doi.org/10.1056/NEJMoa1401105
Devereaux, P. J. ; Mrkobrada, M. ; Sessler, D. I. ; Leslie, K. ; Alonso-Coello, P. ; Kurz, A. ; Villar, J. C. ; Sigamani, A. ; Biccard, B. M. ; Meyhoff, C. S. ; Parlow, J. L. ; Guyatt, G. ; Robinson, A. ; Garg, A. X. ; Rodseth, R. N. ; Botto, F. ; Lurati Buse, G. ; Xavier, D. ; Chan, M. T V ; Tiboni, M. ; Cook, D. ; Kumar, P. A. ; Forget, P. ; Malaga, G. ; Fleischmann, E. ; Amir, M. ; Eikelboom, J. ; Mizera, R. ; Torres, D. ; Wang, C. Y. ; VanHelder, T. ; Paniagua, P. ; Berwanger, O. ; Srinathan, S. ; Graham, M. ; Pasin, L. ; Le Manach, Y. ; Gao, P. ; Pogue, J. ; Whitlock, R. ; Lamy, A. ; Kearon, C. ; Baigent, C. ; Chow, C. ; Pettit, S. ; Chrolavicius, S. ; Yusuf, S. / Aspirin in patients undergoing noncardiac surgery. In: New England Journal of Medicine. 2014 ; Vol. 370, No. 16. pp. 1494-1503.
@article{5431a783f0db437b887a296bed67e2e4,
title = "Aspirin in patients undergoing noncardiac surgery",
abstract = "BACKGROUND: There is substantial variability in the perioperative administration of aspirin in patients undergoing noncardiac surgery, both among patients who are already on an aspirin regimen and among those who are not. METHODS: Using a 2-by-2 factorial trial design, we randomly assigned 10,010 patients who were preparing to undergo noncardiac surgery and were at risk for vascular complications to receive aspirin or placebo and clonidine or placebo. The results of the aspirin trial are reported here. The patients were stratified according to whether they had not been taking aspirin before the study (initiation stratum, with 5628 patients) or they were already on an aspirin regimen (continuation stratum, with 4382 patients). Patients started taking aspirin (at a dose of 200 mg) or placebo just before surgery and continued it daily (at a dose of 100 mg) for 30 days in the initiation stratum and for 7 days in the continuation stratum, after which patients resumed their regular aspirin regimen. The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days. RESULTS: The primary outcome occurred in 351 of 4998 patients (7.0{\%}) in the aspirin group and in 355 of 5012 patients (7.1{\%}) in the placebo group (hazard ratio in the aspirin group, 0.99; 95{\%} confidence interval [CI], 0.86 to 1.15; P = 0.92). Major bleeding was more common in the aspirin group than in the placebo group (230 patients [4.6{\%}] vs. 188 patients [3.8{\%}]; hazard ratio, 1.23; 95{\%} CI, 1.01, to 1.49; P = 0.04). The primary and secondary outcome results were similar in the two aspirin strata. CONCLUSIONS: Administration of aspirin before surgery and throughout the early postsurgical period had no significant effect on the rate of a composite of death or nonfatal myocardial infarction but increased the risk of major bleeding. (Funded by the Canadian Institutes of Health Research and others; POISE-2 ClinicalTrials.gov number, NCT01082874.)",
author = "Devereaux, {P. J.} and M. Mrkobrada and Sessler, {D. I.} and K. Leslie and P. Alonso-Coello and A. Kurz and Villar, {J. C.} and A. Sigamani and Biccard, {B. M.} and Meyhoff, {C. S.} and Parlow, {J. L.} and G. Guyatt and A. Robinson and Garg, {A. X.} and Rodseth, {R. N.} and F. Botto and {Lurati Buse}, G. and D. Xavier and Chan, {M. T V} and M. Tiboni and D. Cook and Kumar, {P. A.} and P. Forget and G. Malaga and E. Fleischmann and M. Amir and J. Eikelboom and R. Mizera and D. Torres and Wang, {C. Y.} and T. VanHelder and P. Paniagua and O. Berwanger and S. Srinathan and M. Graham and L. Pasin and {Le Manach}, Y. and P. Gao and J. Pogue and R. Whitlock and A. Lamy and C. Kearon and C. Baigent and C. Chow and S. Pettit and S. Chrolavicius and S. Yusuf",
year = "2014",
doi = "10.1056/NEJMoa1401105",
language = "English",
volume = "370",
pages = "1494--1503",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "16",

}

TY - JOUR

T1 - Aspirin in patients undergoing noncardiac surgery

AU - Devereaux, P. J.

AU - Mrkobrada, M.

AU - Sessler, D. I.

AU - Leslie, K.

AU - Alonso-Coello, P.

AU - Kurz, A.

AU - Villar, J. C.

AU - Sigamani, A.

AU - Biccard, B. M.

AU - Meyhoff, C. S.

AU - Parlow, J. L.

AU - Guyatt, G.

AU - Robinson, A.

AU - Garg, A. X.

AU - Rodseth, R. N.

AU - Botto, F.

AU - Lurati Buse, G.

AU - Xavier, D.

AU - Chan, M. T V

AU - Tiboni, M.

AU - Cook, D.

AU - Kumar, P. A.

AU - Forget, P.

AU - Malaga, G.

AU - Fleischmann, E.

AU - Amir, M.

AU - Eikelboom, J.

AU - Mizera, R.

AU - Torres, D.

AU - Wang, C. Y.

AU - VanHelder, T.

AU - Paniagua, P.

AU - Berwanger, O.

AU - Srinathan, S.

AU - Graham, M.

AU - Pasin, L.

AU - Le Manach, Y.

AU - Gao, P.

AU - Pogue, J.

AU - Whitlock, R.

AU - Lamy, A.

AU - Kearon, C.

AU - Baigent, C.

AU - Chow, C.

AU - Pettit, S.

AU - Chrolavicius, S.

AU - Yusuf, S.

PY - 2014

Y1 - 2014

N2 - BACKGROUND: There is substantial variability in the perioperative administration of aspirin in patients undergoing noncardiac surgery, both among patients who are already on an aspirin regimen and among those who are not. METHODS: Using a 2-by-2 factorial trial design, we randomly assigned 10,010 patients who were preparing to undergo noncardiac surgery and were at risk for vascular complications to receive aspirin or placebo and clonidine or placebo. The results of the aspirin trial are reported here. The patients were stratified according to whether they had not been taking aspirin before the study (initiation stratum, with 5628 patients) or they were already on an aspirin regimen (continuation stratum, with 4382 patients). Patients started taking aspirin (at a dose of 200 mg) or placebo just before surgery and continued it daily (at a dose of 100 mg) for 30 days in the initiation stratum and for 7 days in the continuation stratum, after which patients resumed their regular aspirin regimen. The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days. RESULTS: The primary outcome occurred in 351 of 4998 patients (7.0%) in the aspirin group and in 355 of 5012 patients (7.1%) in the placebo group (hazard ratio in the aspirin group, 0.99; 95% confidence interval [CI], 0.86 to 1.15; P = 0.92). Major bleeding was more common in the aspirin group than in the placebo group (230 patients [4.6%] vs. 188 patients [3.8%]; hazard ratio, 1.23; 95% CI, 1.01, to 1.49; P = 0.04). The primary and secondary outcome results were similar in the two aspirin strata. CONCLUSIONS: Administration of aspirin before surgery and throughout the early postsurgical period had no significant effect on the rate of a composite of death or nonfatal myocardial infarction but increased the risk of major bleeding. (Funded by the Canadian Institutes of Health Research and others; POISE-2 ClinicalTrials.gov number, NCT01082874.)

AB - BACKGROUND: There is substantial variability in the perioperative administration of aspirin in patients undergoing noncardiac surgery, both among patients who are already on an aspirin regimen and among those who are not. METHODS: Using a 2-by-2 factorial trial design, we randomly assigned 10,010 patients who were preparing to undergo noncardiac surgery and were at risk for vascular complications to receive aspirin or placebo and clonidine or placebo. The results of the aspirin trial are reported here. The patients were stratified according to whether they had not been taking aspirin before the study (initiation stratum, with 5628 patients) or they were already on an aspirin regimen (continuation stratum, with 4382 patients). Patients started taking aspirin (at a dose of 200 mg) or placebo just before surgery and continued it daily (at a dose of 100 mg) for 30 days in the initiation stratum and for 7 days in the continuation stratum, after which patients resumed their regular aspirin regimen. The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days. RESULTS: The primary outcome occurred in 351 of 4998 patients (7.0%) in the aspirin group and in 355 of 5012 patients (7.1%) in the placebo group (hazard ratio in the aspirin group, 0.99; 95% confidence interval [CI], 0.86 to 1.15; P = 0.92). Major bleeding was more common in the aspirin group than in the placebo group (230 patients [4.6%] vs. 188 patients [3.8%]; hazard ratio, 1.23; 95% CI, 1.01, to 1.49; P = 0.04). The primary and secondary outcome results were similar in the two aspirin strata. CONCLUSIONS: Administration of aspirin before surgery and throughout the early postsurgical period had no significant effect on the rate of a composite of death or nonfatal myocardial infarction but increased the risk of major bleeding. (Funded by the Canadian Institutes of Health Research and others; POISE-2 ClinicalTrials.gov number, NCT01082874.)

UR - http://www.scopus.com/inward/record.url?scp=84898651927&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84898651927&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa1401105

DO - 10.1056/NEJMoa1401105

M3 - Article

C2 - 24679062

AN - SCOPUS:84898651927

VL - 370

SP - 1494

EP - 1503

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 16

ER -